MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 4 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was revised due to flexion contracture and instability with her right tka.Surgeon suspects this issue was caused by the patient's poor rehab, and having a bmi of 44.The surgeon wanted to do a debridement and poly exchange, with possible patella revision and possible femur revision.The surgeon was able to do a good debridement after taking out the poly.He was happy being able to get the patient in full extension and good flexion with the poly trial.There was no need in his mind to revision the patella or femur, so he put in a new poly of the same thickness and closed.Doi: (b)(6) 2018, dor: (b)(6) 2020, right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.No code available (3191) is used to capture joint contracture.

• Brand Name: ATTUNE PS FB INSRT SZ 4 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10335245
• Report Number: 1818910-2020-17059
• Device Sequence Number: 16377768
• Product Code: JWH
• UDI-Device Identifier: 10603295049791
• UDI-Public: 10603295049791
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1516-40-406
• Device Catalogue Number: 151640406
• Device Lot Number: J02Z46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE PS FB INSRT SZ 4 6MM; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE PATELLA; ATTUNE PS FB INSRT SZ 4 6MM; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE PATELLA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR